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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

The US Pharmacopeial Convention (USP) and Russia's medical products regulator forged a three-year memorandum of understanding (MOU) earlier this week that will focus on harmonizing major pharmacopeial requirements and promoting the use of modern laboratory standards, among other things.

The agreement, which is an extension of an existing MOU instituted in 2009, means USP and the Federal Service on Surveillance in Healthcare of the Russian Federation (Roszdravnadzor) will cooperate on developing and implementing quality standards for drugs and their ingredients.

"The MOU focuses on enhancing the USP-Roszdravnadzor working relationship through conferences and meetings; joint and mutually-beneficial education and training programs on quality standards; exchanges of scientific staff; promoting harmonization of major pharmacopeial requirements; promoting the use of modern laboratory standards and application of modern metrologic principles (including those incorporated in ISO 17025) and other activities," USP spokeswoman Theresa Laranang-Mutlu told RAPS.

Specifics of Relationship

Since the signing of the original MOU in 2009, USP has worked with staff of the Roszdravnadzor regional quality control laboratories on pharmacopeial education courses. The US non-profit also conducted audits of laboratories, including those in Rostov-on-Don, Kazan, St. Petersburg, Krasnyoyarsk, Khabarovsk and Moscow in the last five years, and several of these quality control labs have received continued and new ISO accreditation for various tests, according to Laranang-Mutlu.

"The audits have included evaluation and, when appropriate, training by USP scientists and independent external auditors on laboratory quality management system. As quality control laboratories that support the regulatory functions of the Roszdravnadzor, these labs are mostly dedicated to the surveillance of product quality in these particular markets. Thus, training that can strengthen their laboratory capabilities better enables them to be compliant with the requirements for ISO 17025 accreditation," she said.

Laranang-Mutlu also explained that since 2009, USP has hosted at least 25 experts from Roszdravnadzor for three one-week international training programs.

In addition, USP hosted three Roszdravnadzor visiting scientists who spent three to four months at USP headquarters in Rockville, Maryland, working on projects related to USP’s standards-setting activities, while most recently, a Roszdravnadzor specialist was selected for the 2015 Visiting Scientists Program.

FDA Collaboration

In addition to USP's work with Roszdravnadzor, the US Food and Drug Administration (FDA) also signed a broad MOU with the Russian drug regulator back in 2010. That agreement included provisions for staff exchanges, promoting regulatory harmonization and collaborating and exchanging expertise on certain topics, such as ensuring the quality of clinical trials and data through adherence to international standards of Good Clinical Practice.